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U.S. Department of Health and Human Services

Class 3 Device Recall Orthofix Bone Marrow Aspiration Needle

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  Class 3 Device Recall Orthofix Bone Marrow Aspiration Needle see related information
Date Initiated by Firm October 18, 2010
Date Posted December 10, 2010
Recall Status1 Terminated 3 on February 28, 2011
Recall Number Z-0590-2011
Recall Event ID 57011
510(K)Number K913306  
Product Classification Bone marrow collection/transfusion kit - Product Code LWE
Product Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, probe, probe guide, and universal cap. Cannula is available as an 8 gauge needle or 11 gauge needle.
Code Information Lot numbers L0J124, L0D175, L9K206 and L9E218
Recalling Firm/
Manufacturer
Orthofix Inc
3451 Plano Parkway
Lewisville TX 75056-9453
Manufacturer Reason
for Recall
Outer cartons for the product may be labeled with incorrect needle gauge.
FDA Determined
Cause 2
Other
Action Orthofix issued an Urgent Product Recall letter dated October 14, 2010 to consignees. Customers were instructed to inspect their inventory, and remove and return affected product to the firm. Replacement needles will be provided. Orthofix account representatives can be contacted at 1 888 298 5700, and Orthofix Regulatory Affairs can be contacted at 1 214 937 2061.
Quantity in Commerce 274
Distribution Worldwide Distribution - USA, including the states of AL, AR, CA, CT, FL, LA, MI, MO, NC, NJ, NY, PA, SC, and TX, and the country of Spain.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LWE and Original Applicant = PROACT, LTD.
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